Mechanical assembly including exterior surface preparation

ABSTRACT

A system and method for further improving upon an ability of a surgeon to reduce or eliminate impaction forces when installing or assembling a prosthesis. An implant includes a surface treatment for aiding operations with the implant. For example, some surface treatments provide an asymmetry in installation versus removal to bias the associated implant deeper into an installation site.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims benefit of U.S. Patent Application No.62/319,377 filed 7 Apr. 2016 and also is related generally to U.S.Patent Application No. 61/921,528 filed 29 Dec. 2013, to U.S. PatentApplication No. 61/980,188 filed 16 Apr. 2013, U.S. patent applicationSer. No. 14/584,656 filed 29 Dec. 2014 (now U.S. Pat. No. 9,168,154), toU.S. patent application Ser No. 14/585,056 filed 29 Dec. 2014 (now U.S.Pat. No. 9,220,612), to U.S. patent application Ser. No. 14/923,203filed 26 Oct. 2015, to U.S. patent application Ser. No. 14/969,721 filed15 Dec. 2015, to U.S. Patent Application No. 62/277,294 filed 11 Jan.2016, to U.S. patent application Ser. No. 14/965,851 filed 10 Dec. 2015,to U.S. patent application Ser. No. 15/055,942 filed 29 Feb. 2016, andto U.S. patent application Ser. No. 15/092,384 filed 6 Apr. 2016, allthe contents of which are all hereby expressly incorporated in theirentireties by reference thereto for all purposes.

FIELD OF THE INVENTION

The present invention relates generally to mechanical assembly andassemblies, and more specifically, but not exclusively, to a prosthesisincluding its construction, assembly, and installation.

BACKGROUND OF THE INVENTION

The subject matter discussed in the background section should not beassumed to be prior art merely as a result of its mention in thebackground section. Similarly, a problem mentioned in the backgroundsection or associated with the subject matter of the background sectionshould not be assumed to have been previously recognized in the priorart. The subject matter in the background section merely representsdifferent approaches, which in and of themselves may also be inventions.

The incorporated patents and applications often address a problem ofapplied forces in the assembly and installation of mechanical systems,such as a prosthesis used in orthopedic surgery.

There are many considerations regarding the use of applied impact forcesin orthopedic surgery and in particular the use of a hammer or a malletto apply an impact force. Much work has been done to help understand,control, modulate, and replace the impaction forces created by thesurgeon's mallet. Some of the incorporated references have describedvarious components of these applied forces, often using orthopedics asan example though the invention is not required to be so limited. Theuse of a mallet in orthopedics creates a momentum or an impulse andeffects of the impulse in creating an impaction force can be broken downinto its components, including magnitude, frequency and dwell time. Someof the incorporated references include systems and methods ofsubstituting an installation force for the impaction force in orthopedicsurgery. Embodiments of the incorporated references may allow thesurgeon to perform some of these surgeries in a safer and morecontrolled fashion by rethinking conventional procedures related to aprosthesis. Further, some of the incorporated references relate toassembly of a prosthesis for use in an orthopedic procedure.

The collection of incorporated references include multiple embodimentsof multiple inventions, with some of these embodiments including a useof vibratory force/energy that disclosed as important for addressingproblems with application of impaction forces.

In some of the embodiments of the incorporated patents and applications,there is a discussion that there may be significant advantage to use ofcontrolled installation forces communicated to a prosthesis orprosthesis component at higher (including ultrasonic) frequencies. Someor a significant portion of these advantages may relate to differencesbetween kinetic and static coefficients of friction, and/or vibratorymodes of the installation site (bone) or mating component for aprosthetic assembly, among other possible explanations. These featuresmay allow a prosthesis (or portion thereof) vibrating at an appropriatemode to diminish, sometimes significantly, forces resisting installationor assembly, respectively. With these diminished forces, the surgeon maybe able to employ decreased installation forces which allow easier andsafer insertions. In some embodiments, the embodiment may allow for aconcurrent ability to align the prosthesis during/after installation aspart of the same procedure with the same tools. This is in contrast toconventional systems which employ one set of tools for insertion andthen another set of tools after insertion to correction malpositioning.Some embodiments of the present invention may allow for concurrentinsertion and desired positioning.

Current surface treatment of a prosthesis is designed for porous metalingrowth bonding of a prosthesis to bone (in contrast to a use of cementto bond a prosthesis to bone). In general the porous implants aretypically created as “composite structures” consisting of a substratetypically made of either cobalt chrome or titanium alloy (which carriesthe patient's weight), and a porous surface which is designed to enhanceosseointegration of the implant (referred to as “porous coating”). Theporous coating includes microstructural features such as peaks, valleysand deep caves. This mimics the structure of trabecular/cancellous bonewith its three-dimensional and interconnecting network of pores andcapillary properties. The porous coating aids in initial scratchfixation as well as long term fixation through osseointegration of bonewith the surface of the bone. Recently, there have been many advances inthe creation of the porous coating that more accurately resemble thetrabecular bone. These techniques all involve multiple steps in thecreation of the porous coating surface and subsequent bonding of thissurface to the alloy substrate. Today, the majority of porous coatingsare made of titanium or tantalum. These porous coatings are texturedwith desirable mechanical properties closer to bone and with desirableporosity. They are created separately and applied to the actual implant(as a composite structure) via variety of bonding methods includingplasma spray, chemical etching thin films and plates, chemical and/orphysical vapor disposition, sintering, brazing, diffusion bonding,gluing or cementing, and the like). Thus, the porous coating that isseen on the surface of a typical conventional prosthesis is: i) acomposite structure that must to be added to the substrate, and ii) arandomized pattern with no preferential orientation and or design.

Fixation of hip and knee replacement implants to bone is critical to thesuccess of the procedure. A variety of roughened surfaces andthree-dimensional (3-D) porous surfaces have been used to enhancebiological fixation on orthopedic implants for over 30 years. Morerecently, highly porous metals have emerged as versatile biomaterialsthat may enhance fixation to bone and are suitable to a number ofapplications in hip and knee replacement surgery. The advantagesprovided by these newly developed porous metals may improve cementlessfixation and long-term patient outcomes in hip and knee replacement.

Thermal spray technologies involving the melting and subsequent sprayingof metal feedstock have been leveraged by various implant manufacturersto apply highly roughened commercially pure titanium (CPTi) and titanium(Ti) alloy coatings onto implants used in hip and knee arthroplasty.These include: wire arc deposition, plasma spray, sintering porousbeads, diffusion bonding of titanium coatings, advanced highly porouscoating technologies using tantalum and titanium, among otherprocedures.

Current installation procedures for some prosthesis, such as for anacetabular cup, include attachment of a rod axially aligned with alongitudinal axis of the prosthesis that is used to apply the impactingforces and impact the prosthesis into the bone to the desired depth.

What is needed is a system and method for further improving upon anability of a surgeon to reduce or eliminate impaction forces wheninstalling or assembling a prosthesis.

BRIEF SUMMARY OF THE INVENTION

Disclosed is a system and method for improving upon an ability of asurgeon to reduce or eliminate impaction forces when installing orassembling a prosthesis.

The following summary of the invention is provided to facilitate anunderstanding of some of the technical features related to surfacetreatment for mating/contacting surfaces of a prosthesis or a prosthesiscomponent, and is not intended to be a full description of the presentinvention. A full appreciation of the various aspects of the inventioncan be gained by taking the entire specification, claims, drawings, andabstract as a whole. The present invention is applicable to otherprosthesis devices in addition to acetabular cups, to other mechanicalsystems for reduced force insertion of one structure into another, andto other configurations and arrangements of exterior surface structuresthan those presented or described herein.

In an embodiment of the present invention, an implant may include asurface treatment for aiding operations with the implant. For example,some surface treatments provide an asymmetry in installation versusremoval to bias the associated implant deeper into an installation site.

An embodiment of the present invention includes a surface treatment,whether produced as an innate outer surface feature of the device duringmanufacture or added to a surface (e.g., an outer surface) of a device,such as, for example, a retrofit solution. The surface treatmentprovides an asymmetric relative force for the device in cooperation withmaterial of an installation side (e.g., easier to push the prosthesisinto a bone than to extract the prosthesis from the bone). For example,the treatment includes provision of various exterior structures thatinteract with material of the installation site more strongly in onerelative direction (e.g., removal or disassembly from the installationsite) than in another direction (e.g., insertion or assembly into theinstallation site). For example, the surface treatment of the prosthesiscollectively offers less resistance to installation than removal.

An embodiment of the present invention may provide for both asymmetricrelative forces while also including enough randomization for porousingrowth of bone for post-installation bonding enhancement. The surfacetreatment and/or the ingrowth structures may be microscopic and/ormacroscopic.

An embodiment of the present invention may include exterior surfacestructures and configurations that provide an acute angle relative to aninsertion path. For example, when installing an acetabular cup into aprepared installation site of an acetabulum, the cup follows a path asit is inserted into the desired location and depth. Exterior surfaceportions of the cup are in contact with, and move past, the bone of thewalls of the installation site. For one type of surface treatment,exterior surface structures of the surface treatment could be angledrelative to the walls. The angles could be angled acutely forward (e.g.,towards a bottom of the installation site) which may increaseinstallation forces and decrease removal forces, angled perpendicularlywhich may be neutral as to directionally, and/or angled backward (e.g.,away from the bottom of the installation site) which may increaseremoval forces and decrease installation forces. The magnitude, anddifferences, of these asymmetric forces may be influenced by manydifferent factors including materials of the exterior surface elementsand complementary material of the contacting surfaces of theinstallation site, characteristic size and arrangement of the exteriorsurface elements, design goals, and/or intended use.

An embodiment of the present invention may include exterior surfacestructures and configurations that provide pitched structures, relativeto an insertion path, that vary over the surface that provide forasymmetric relative installation forces.

An embodiment of the present invention may include a speciallyconfigured exterior surface to present a two-dimensional or athree-dimensional variable stiffness that is more conducive fortransmission of force and energy longitudinally (e.g., parallel to theinsertion path) and less conducive to circumferential transmission(e.g., perpendicular to the insertion path). That is, there is anasymmetry of the structural response of the surface treatment to make iteasier to move along the path while retaining the circumferentialintegrity for being held in place once installed.

An embodiment of the present invention may include use of additivemanufacturing techniques to produce a final prosthesis having anintegrated surface treatment that may not require a multi-step processof applying a porous surface treatment to an underlying prostheticfoundation.

An embodiment of the present invention may include use of subtractivemanufacturing techniques to produce a final prosthesis having anintegrated surface treatment that may not require a multi-step processof applying a porous surface treatment to an underlying prostheticfoundation.

An embodiment of the present invention may include a differentinstallation adaptor for applying forces used to locate a prosthesiswithin a bone. The conventional method of using an apex-attached rod toapply the forces may be thought of as “pulling” the prosthesis throughthe installation site. In contrast, an embodiment may include anattachment modality or adaptor that operates on the perimeter and/orinside surfaces to push the prosthesis through the bone. Theseembodiments may implicate other embodiments regarding 2D/3D wallconfiguration for interacting the prosthesis with the installation site.

Any embodiment of the present invention may be superior throughmanipulation of the friction between contacting surfaces of theprosthesis relative to the material of the installation site. The BMD3vibratory mechanism may contribute to shifting some or all of thefrictional forces from a static coefficient of friction regime to akinetic coefficient of friction regime. Other factors may also becontributing to a reduction in installation forces required. Similarly,some of the effects of the surface treatment and/or surface applicationmay implicate, at least partially, a transformation of some or all ofthe resistive forces into the kinetic coefficient of friction regime.

Any of the embodiments described herein may be used alone or togetherwith one another in any combination. Inventions encompassed within thisspecification may also include embodiments that are only partiallymentioned or alluded to or are not mentioned or alluded to at all inthis brief summary or in the abstract. Although various embodiments ofthe invention may have been motivated by various deficiencies with theprior art, which may be discussed or alluded to in one or more places inthe specification, the embodiments of the invention do not necessarilyaddress any of these deficiencies. In other words, different embodimentsof the invention may address different deficiencies that may bediscussed in the specification. Some embodiments may only partiallyaddress some deficiencies or just one deficiency that may be discussedin the specification, and some embodiments may not address any of thesedeficiencies.

An embodiment of the present invention may be adapted for impactinstallation and is not limited to other non-impactful installationprocedures which may reduce a magnitude of the impact force needed andwhich may reduce risks of shattering bone at the installation site.

An embodiment of the present invention may include a cream, paste, gel,or other substance that may be applied to contacting surfaces of aprosthesis to be forced into an installation site. This surfacetreatment may function similar to a lubricant or “shaving cream” toallow to contacting surfaces to more easily move past each other andreduce a magnitude of forces used for an installation. This surfacetreatment may be combined with other disclosed embodiments and may bedynamically applied as the prosthesis is about to be installed at theinstallation site.

An embodiment of the present invention may include use of the disclosedembodiments and implementations for assembling a prosthesis (insertingone component of a modular prosthesis into a mating receptacle ofanother component of the modular prosthesis).

Other features, benefits, and advantages of the present invention willbe apparent upon a review of the present disclosure, including thespecification, drawings, and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, in which like reference numerals refer toidentical or functionally-similar elements throughout the separate viewsand which are incorporated in and form a part of the specification,further illustrate the present invention and, together with the detaileddescription of the invention, serve to explain the principles of thepresent invention.

FIG. 1 illustrates a sectional side view of an embodiment of the presentinvention;

FIG. 2 illustrates a sectional side view of an embodiment of a surfacetreatment;

FIG. 3 illustrates a sectional side view of an embodiment of the surfacetreatment of FIG. 2 applied to a prosthesis of FIG. 1;

FIG. 4 illustrates a sectional side view of an alternative embodiment ofa surface treatment;

FIG. 5 illustrates a representative sectional side view of an embodimentof the alternative surface treatment of FIG. 4 applied to a prosthesisof FIG. 1;

FIG. 6 illustrates a side view of a prosthesis including atwo-dimensional asymmetrical stiffness;

FIG. 7 illustrates a top view of the prosthesis of FIG. 6;

FIG. 8 illustrates a side view of a pulling of a prosthesis along aninstallation path responsive to an apex-attached force applicator;

FIG. 9 illustrates a side view of a pushing of a prosthesis along aninstallation path responsive to a whole-surface interior adaptor forceapplicator; and

FIG. 10 illustrates a side view of the whole-surface interior adaptorforce application disengaged from the prosthesis to better illustrateits configuration.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the present invention provide a system and method forfurther improving upon an ability of a surgeon to reduce or eliminateimpaction forces when installing or assembling a prosthesis. Thefollowing description is presented to enable one of ordinary skill inthe art to make and use the invention and is provided in the context ofa patent application and its requirements.

Various modifications to the preferred embodiment and the genericprinciples and features described herein will be readily apparent tothose skilled in the art. Thus, the present invention is not intended tobe limited to the embodiment shown but is to be accorded the widestscope consistent with the principles and features described herein.

Definitions

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this general inventive conceptbelongs. It will be further understood that terms, such as those definedin commonly used dictionaries, should be interpreted as having a meaningthat is consistent with their meaning in the context of the relevant artand the present disclosure, and will not be interpreted in an idealizedor overly formal sense unless expressly so defined herein.

The following definitions apply to some of the aspects described withrespect to some embodiments of the invention. These definitions maylikewise be expanded upon herein.

As used herein, the term “or” includes “and/or” and the term “and/or”includes any and all combinations of one or more of the associatedlisted items. Expressions such as “at least one of,” when preceding alist of elements, modify the entire list of elements and do not modifythe individual elements of the list.

As used herein, the singular terms “a,” “an,” and “the” include pluralreferents unless the context clearly dictates otherwise. Thus, forexample, reference to an object can include multiple objects unless thecontext clearly dictates otherwise.

Also, as used in the description herein and throughout the claims thatfollow, the meaning of “in” includes “in” and “on” unless the contextclearly dictates otherwise. It will be understood that when an elementis referred to as being “on” another element, it can be directly on theother element or intervening elements may be present therebetween. Incontrast, when an element is referred to as being “directly on” anotherelement, there are no intervening elements present.

As used herein, the term “set” refers to a collection of one or moreobjects. Thus, for example, a set of objects can include a single objector multiple objects. Objects of a set also can be referred to as membersof the set. Objects of a set can be the same or different. In someinstances, objects of a set can share one or more common properties.

As used herein, the term “adjacent” refers to being near or adjoining.Adjacent objects can be spaced apart from one another or can be inactual or direct contact with one another. In some instances, adjacentobjects can be coupled to one another or can be formed integrally withone another.

As used herein, the terms “connect,” “connected,” and “connecting” referto a direct attachment or link. Connected objects have no or nosubstantial intermediary object or set of objects, as the contextindicates.

As used herein, the terms “couple,” “coupled,” and “coupling” refer toan operational connection or linking. Coupled objects can be directlyconnected to one another or can be indirectly connected to one another,such as via an intermediary set of objects.

The use of the term “about” applies to all numeric values, whether ornot explicitly indicated. This term generally refers to a range ofnumbers that one of ordinary skill in the art would consider as areasonable amount of deviation to the recited numeric values (i.e.,having the equivalent function or result). For example, this term can beconstrued as including a deviation of ±10 percent of the given numericvalue provided such a deviation does not alter the end function orresult of the value. Therefore, a value of about 1% can be construed tobe a range from 0.9% to 1.1%.

As used herein, the terms “substantially” and “substantial” refer to aconsiderable degree or extent. When used in conjunction with an event orcircumstance, the terms can refer to instances in which the event orcircumstance occurs precisely as well as instances in which the event orcircumstance occurs to a close approximation, such as accounting fortypical tolerance levels or variability of the embodiments describedherein.

As used herein, the terms “optional” and “optionally” mean that thesubsequently described event or circumstance may or may not occur andthat the description includes instances where the event or circumstanceoccurs and instances in which it does not.

As used herein, the term “size” refers to a characteristic dimension ofan object. Thus, for example, a size of an object that is spherical canrefer to a diameter of the object. In the case of an object that isnon-spherical, a size of the non-spherical object can refer to adiameter of a corresponding spherical object, where the correspondingspherical object exhibits or has a particular set of derivable ormeasurable properties that are substantially the same as those of thenon-spherical object. Thus, for example, a size of a non-sphericalobject can refer to a diameter of a corresponding spherical object thatexhibits light scattering or other properties that are substantially thesame as those of the non-spherical object. Alternatively, or inconjunction, a size of a non-spherical object can refer to an average ofvarious orthogonal dimensions of the object. Thus, for example, a sizeof an object that is a spheroidal can refer to an average of a majoraxis and a minor axis of the object. When referring to a set of objectsas having a particular size, it is contemplated that the objects canhave a distribution of sizes around the particular size. Thus, as usedherein, a size of a set of objects can refer to a typical size of adistribution of sizes, such as an average size, a median size, or a peaksize.

FIG. 1 illustrates a sectional side view of an embodiment of the presentinvention represented using a prosthesis 100 including a foundationportion 105 and an exterior contacting portion 110. In some cases,prosthesis 100 may include an optional mounting structure 115 attachedto, or integrated with, an interior wall 120.

Prosthesis 100 in FIG. 1 is an acetabular cup used in total hipreplacement medical procedures. Prosthesis 100 is installed into aprepared installation site of an acetabulum that defines a reamed socketin a portion of bone of an acetabulum that is about equal to a diameterof the acetabular cup. When installed, exterior contacting portion 110contacts the bone portion of the installation site. Installation of anacetabular cup requires that it be forced into the installation sitewhile exterior contacting portion 110 is engaged, in varying degrees,with the living bone. Some of the disclosed embodiments providematerials, configuration, arrangement, and orientation of surfaceelements defined by exterior contacting portion 110 that provide,collectively, an overall asymmetric force with respect to one or more ofthe contacted portions of the bone portion. In this context, asymmetricforce means that engagement forces between the bone portion andprosthesis 100 have a magnitude in one direction of motion (e.g. deeperinto the installation) as compared to another direction (e.g., removalfrom the installation site) that are different. For example, contactingportion 110 may result in installation forces with respect to theinstallation site that are less than removal forces from theinstallation site once installed. Other directions and other asymmetriesare possible that for some embodiment it may be desirable to haveinstallation forces be greater than removal forces. A magnitude of theasymmetry may be determined by different factors appropriate for aparticular embodiment.

Prosthesis 100 depicted as including at least two portions: foundationportion 105 and exterior contacting portion 110 which is not meant toimply any particular manufacturing process, configuration, orarrangement beyond the presence of two functional portions.

Foundation portion 105 may be thought of as providing structuralintegrity and strength for weight-bearing and loading, and support forexterior contacting portion 110. Exterior contacting portion 110 definesthe surface elements that produce aggregate asymmetric forces duringcontacted motion with bone of the installation site.

Foundation portion 105 and exterior contacting portion 110 may be formedin many different ways. As illustrated in FIG. 1, exterior contactingportion 110 is integrally produced with foundation portion 105 duringmanufacturing of prosthesis 100. For example, additive manufacturingtechniques may be used to define the different portions at differentpoints during the manufacturing. Three-dimensional (3D) printing is arepresentative class of additive manufacturing equipment that may beused to seamlessly produce prosthesis 100 with exterior contactingportion 110 seamlessly integrated with foundation portion 105.

In other embodiments, prosthesis 100 may be produced using a two-stepprocess in which foundation portion 105 is manufactured first and thenin a separate manufacturing process exterior contacting portion 110 isadded onto desired surfaces of foundation portion 105 to produceprosthesis 100. In some cases, exterior contacting portion 110 may beproduced first as a template and then foundation portion added later.

For purposes of this invention, the term “surface treatment” is used toinclude all these implementations of exterior contacting portion 110.This term is not limited to any particular arrangement or configurationof exterior contacting portion 110.

As noted herein, one desirable feature of current prosthetic implantsincludes a surface arrangement for a randomized exterior that includespores/cavities/voids of a particular characteristic that are used topromote bone in-growth for bonding prosthesis 100 at the installationsite. Some configurations of exterior contacting portion 110 may beconfigured with such in-growth bonding features implemented consistentwith the manufacturing technique for prosthesis 100. The surfacetreatment itself may include a microscopic and/or a macroscopiccharacteristic dimensions for the implementing structural elements.

For example, with the use of additive manufacturing, the set ofinstructions for forming prosthesis 100 result from a set ofinstructions executed by the additive manufacturing equipment. That setof instructions may be defined by various 3D design tools and variousmathematical instructions. Those instructions may include asuperposition of asymmetric structural elements and randomizedvoid-definition processes such that exterior contacting portion 110includes both of these characteristics. In other embodiments,void-definition processes may be applied to prosthesis 100 afterexterior contacting portion 110 is produced with asymmetric forceproducing structures. Similarly, asymmetric biasing structures may belater added to a device having existing ingrowth structures.

In some cases, prosthesis 100 may be provided with mounting structure115 which may be implemented in many different ways and used as amechanism to secure an external tool to prosthesis 100. In one case,structure 115 may include a solid structure attached at an apex ofinterior surface 120. That solid structure may further define anexternally accessible cavity including threaded sidewalls. The externaltool may include an extension having an exterior threaded surfacecomplementary to the threaded sidewalls of structure 115.

In use, an operator may attach the external tool (an example isillustrated later in FIG. 8) to mounting structure 115 and begin toapply an inserting force prosthesis 100 into an installation site. Thatinserting force may be a non-impacting force applied by a BMD-typedevice as described in the incorporated patents and applications or itmay be an impacting force applied by a mallet, hammer, or the like.Exterior contacting portion 110 may be configured so a netinsertion-resisting force relative to the side walls of the installationis less than a net withdrawal-resisting force relative to the sidewalls. This arrangement may allow for decreased installation forces asopposed to a prosthesis having an outer surface with symmetric orrandomized resisting forces. In some implementations, each incrementaldepth increase may be performed with less inserting force and eachposition may be thought of being anchored in place with a bias toincreasing the installation depth responsive to forces applied to and bythe external tool.

In some embodiments, when the asymmetric forces have enoughdifferential, and when the installation site is prepared in anappropriate fashion, some embodiments may allow for insertion to resultfrom generalized low-level vibration or periodic forces that biasprosthesis ever deeper into the installation site.

FIG. 2 illustrates a sectional side view of an embodiment of a surfacetreatment 200. Surface treatment 200 includes a series of asymmetric“steps” that may be included as all, or a portion of, exteriorcontacting portion 110, extending 360 degrees around foundation portion105 when viewed from above. FIG. 3 illustrates a sectional side view ofa surface treatment 200 included as part of prosthesis 100 as exteriorcontacting portion 110. In some embodiments, surface treatment 200 maynot extend over an entire height of prosthesis 100. In some embodiments,surface treatment 200 may not include a regular step profile. The stepprofile of surface treatment 200 is representative of asymmetricallyangled surface elements of the type that may be used for asymmetricresisting forces.

FIG. 4 illustrates a sectional side view of an alternative embodiment ofa surface treatment 400. Surface treatment 400 illustrates a concept ofvariable pitch in which a first distance 405 between a first set ofadjacent peaks of surface treatment 400 is different than a seconddistance 410 between a second set of adjacent peaks of surface treatment400. There are many different possible implementations for surfacetreatment 400. While surface treatment 400 is illustrated as havingcontinuously variable distances between a pair of peaks, surfacetreatment 400 may also be implemented as having a first portion ofsubstantially matching (or varying using a first variable peak profile)pitch distances and then having one or more additional portions, eachportion including substantially matching (or varying using the same oradditional variable peak profiles) pitch distances within its portion.That is to say, a top portion, perhaps a top quarter or a top third ofprosthesis 100, for example, may include a first configuration forpitches as part of surface treatment 400 while a bottom portion, perhapsa bottom quarter or a bottom third of prosthesis 100, for example, mayinclude a second configuration for pitches as part of surface treatment400. FIG. 5 illustrates a representative sectional side view of surfacetreatment 400 included with prosthesis 100 as exterior contactingportion 110. The variable pitches may provide for asymmetric resistingforces. As illustrated, surface treatment 400 includes a generallysymmetric peak pattern. In some embodiments, surface treatment 400 mayinclude a modification of surface treatment 200 to include one or moreregions of variably spaced “asymmetrically-angled peaks” when includedas part of exterior contacting portion 110.

The distribution of these portions may be other than this example (topand bottom portions) and different regions and portions may havedifferent expanses (e.g., a top third and a bottom quarter) for example.In other embodiments, exterior contacting portion 110 may include one ormore regions of surface treatment 200 and one or more regions of surfacetreatment 400.

FIG. 6 illustrates a side view of a prosthesis 600 including atwo-dimensional asymmetrical stiffness configuration, and FIG. 7illustrates a top view of prosthesis 600. Prosthesis 600 includes a setof ribs 605 and one or more planks 610 disposed as part of a prostheticbody 615, represented as an alternative acetabular cup. Body 615 may beimplemented in conventional fashion or may include an arrangementconsistent with prosthesis 100. Ribs 605 and plank(s) 610 are configuredto provide an asymmetric two-dimensional (2D) stiffness to body 615 thatmay be more conducive to transmission of force and energy through thelongitudinal axis of the cup as opposed to circumferentially. Ribs 605are longitudinally extending inserts within body 615 (and/or applied toone or more exterior surfaces of body 615). Plank(s) 610 is/arelaterally extending circumferential band(s) within body 615 (and/orapplied to one or more exterior surfaces of body 615). For example,planks 610 may be “stiffer” than ribs 605 (or vice-versa) to produce adesired asymmetric functional assembly that may provide for anundulatory body motion as it is installed into position.

The illustration of FIG. 6 is not to be understood as implying that thepresent invention requires that ribs and planks be maintained atrelative right angles as illustrated. In some implementations, toachieve a desired affect or motion, other angular relationships betweenthe ribs and planks are possible (e.g., 30, 45, 60 degree relationships,or more generally an angular (which may be constant or varying atdifferent locations) range of 5-90 degrees.

An alternate implementation could include other arrangements ofintersecting multidimensional (e.g., 2D or 3D structures) such as a pairof counter-cyclical helical structures implemented in a body of aprosthesis. That is, for a prosthesis having a particular axis, onestructure is installed clockwise about that axis and another structureis installed counter-clockwise about that axis. The frequency of wrap,material type, tension, nature of integration, and other factorsinfluence the asymmetric stiffness imparted by these structures that inturn may influence a resulting undulatory motion in response to forcesmoving the prosthesis along an installation path. In some cases, it maybe desired to provide a particular undulation motion for removal ratherthan for installation as the present invention is not constrained tojust improving installation of a prosthesis into a bone.

In some embodiments, a use of a tool, for example a BMD prototype,allows an operator to insert a prosthesis with more control and lessforce. Use of such a tool coupled with prosthesis 600 that has anasymmetrical “structural” and hence asymmetrical “functional” propensityfor longitudinal seating, the operation may be able to be completed withless force, and thus more safely, efficiently, and/or accurately.

The acetabular cup and all implants in orthopedic surgery may benefitfrom various types of differentiation (where the structure of theimplant in and by itself) enhances the functionality of the implant.Prosthesis 600 may alternatively, or in addition, include a “crosshelical arrangement” of fibers, strands, cables, ropes, or otherstructures to be simulated on the surface of, or in the body of,prosthetic implants (e.g., acetabular cups) and hence the creation of“two dimensional stiffness”. The creation of “fiber angels” on thesurface of the implant creates better and easier seating of the implant,with more efficient transmission of force from an insertional tool tothe cup (implant) to the pelvic bone.

Prosthesis 600 may be referred to generally as an “intelligentprosthesis” and acetabular cup where the manipulation of the structureand surface of the implant significantly affects the functionality ofthe implant particularly during the actual surgery, this implant willhave been fine-tuned functionally to insert. This cup through itsinherent structural specifications discussed above will complement theuse of BMD vibratory insertional tool (bidirectional or unidirectionalversions). This concept may applies to many different orthopedicimplants used for reconstruction and trauma, and other structures to beinserted or assembled together.

FIG. 8 illustrates a side view of a system 800 pulling a prosthesis 805along an installation path responsive to an apex-attached forceapplicator 810. In some cases for a prosthesis having 2D functionalasymmetry, it may be desirable or undesirable to pull prosthesis 805 insuch as fashion depending upon the differing moduli of stiffness andarrangement of components. In some arrangements, it may be undesirableto pull prosthesis into position in the manner illustrated in FIG. 8.

FIG. 9 illustrates a side view of a system 900 pushing of prosthesis 905(e.g., prosthesis 600) along an installation path responsive to awhole-surface interior adaptor force applicator 910, and FIG. 10illustrates a side view of system 900 with whole-surface interioradaptor force applicator 910 disengaged from prosthesis 905 to betterillustrate its configuration. Applicator 910 sits into prosthesis 905and “pushes” it down into position. In some embodiments may provide that“pushing” prosthesis 905 into position with applicator 910 (such as aBMD or a BMD-type device) possibly engages an undulatory motion ofprosthesis 905 more effectively, such as in some cases when prosthesis905 includes an embodiment of prosthesis 600 configured for undulationin response to an appropriate series longitudinal insertion forces F.s

Another embodiment of the present invention may include a materialapplied alone or as part of another surface treatment to contactingsurfaces of a prosthesis. This embodiment includes a completely novelidea for insertion of a prosthesis such as an acetabular cup. Dependingupon context, there are materials that may significantly decreaserelative friction between two contacting objects moving past each other.A use of a BMD vibrational tool may help to facilitate the use ofsimilar concept. An embodiment may include a bio-absorbable orbio-degradable material (e.g., a paste, cream, gel, or other substance)configured for use during the insertion process, e.g., of an acetabularcup into the acetabulum, to decrease the relative forces betweencontacting surfaces at the cup and bone interface. For example, thismaterial could be an antibiotic paste that absorbs immediately afterinsertion, or a rapidly dissolving paste such as calcium hydroxylapatite(HA) [Ca10(OH)2 (PO4)6], Beta tricalcium phosphate, an HA/B TCPcombination; all of which can be made into paste and slurries thatdissolve over controlled amounts of time. An embodiment of the presentinvention may include use of a surface-applied material (such as acream, gel, paste or the like) to minimize relative forces during theinsertion/assembly of an implant with a tool, such as the BMD prototypeor other installation tool. Of course this idea applies to otherimplants, for example those that require the use of force and that wouldbenefit from the BMD vibrational insertion tool, as well as otherprocedures and tools.

Surface treatment and/or application of a surface material may reduceinstallation forces. One possible theory, is that the surface treatmentand/or surface material manipulates of the applicable frictioncoefficients through shifting a contribution from static to kineticcoefficients as well as reducing the applicable static and/or kineticcoefficient. For a surface treatment such as a paste, slurry, ice, orthe like, such manipulation may be temporary during the time that theprosthesis is installed. Thereafter the values for the coefficients mayrevert to the previous, unaltered values. This may be used to advantagein helping to improve the retentive forces holding the prosthesis inplace after installation.

Described herein is use of a paste or slurry that absorbs over timeafter installation (in some cases quickly such as ice) after theinsertion (HA) [Ca10 (OH)2 (PO4)6], Beta tricalcium phosphate, and HA/BTCP combination, all of which may be made into a paste and/or a slurrythat can be applied to the surface of the cup and dissolve over acontrolled period of time, preferably immediately after the insertion ofthe cup is complete. In addition, there is another concept that uses amore simple and ubiquitous phenomena to reduce installation forces(e.g., possibly to reduce the applicable coefficients of friction), inorder to allow easier insertion of the acetabular prosthesis into theacetabulum. That is to create a simple method of freezing sterile wateron the cup and within the porous coating surface of the cup to provide afull or partial ice film at the juncture of the cup and the bone of theinstallation site. The porous coating comprises of microstructuralfeatures such as peaks, valleys and deep caves. In one sense, thisstructure may mimic the structure of trabecular/cancellous bone with itsthree-dimensional and interconnecting network of pores and capillaryproperties. The porous coating aids in initial scratch fixation as wellas long term fixation through osseointegration of bone with its surface.Recently, there have been many advances in the creation of the porouscoating that more accurately resemble the trabecular bone. Filling thesegaps with sterile ice water that is then frozen is expected todramatically decrease the applicable installation forces (possibly byreducing the applicable coefficients of friction) and hence FR(resistive force for insertion of a cup into a cavity). This method ofusing ice water is ideal in that as soon as the cup is exposed to thebody fluids the ice will melt returning the coefficient of staticfriction (for the cup/cavity interface) to its original value before theapplication of ice. In this manner whether a biological paste,antibiotic paste, or ice is utilized, the coefficient of static frictionmay be temporarily (disarmed) so that easy insertion can occur. All ofthese methods whether they rely on the paste, slurry or ice perform thesame function to temporarily diminish the FR or applicable resistiveforce(s) for the cup/cavity interaction, and resolve shortly afterinsertion, and thereby return the relative forces to unalteredvalues—except that after installation these resistive now resist removalin contrast to resisting installation. This is akin to “tricking” thebody to open up a short window of time to allow easy insertion of aprosthesis. This is a new and novel method that can be utilized to makeacetabular cup insertion easier with any insertion tool or method,including with the disclosed and incorporated devices, systems, andmethods.

The system and methods above has been described in general terms as anaid to understanding details of preferred embodiments of the presentinvention. In the description herein, numerous specific details areprovided, such as examples of components and/or methods, to provide athorough understanding of embodiments of the present invention. Somefeatures and benefits of the present invention are realized in suchmodes and are not required in every case. One skilled in the relevantart will recognize, however, that an embodiment of the invention can bepracticed without one or more of the specific details, or with otherapparatus, systems, assemblies, methods, components, materials, parts,and/or the like. In other instances, well-known structures, materials,or operations are not specifically shown or described in detail to avoidobscuring aspects of embodiments of the present invention.

Reference throughout this specification to “one embodiment”, “anembodiment”, or “a specific embodiment” means that a particular feature,structure, or characteristic described in connection with the embodimentis included in at least one embodiment of the present invention and notnecessarily in all embodiments. Thus, respective appearances of thephrases “in one embodiment”, “in an embodiment”, or “in a specificembodiment” in various places throughout this specification are notnecessarily referring to the same embodiment. Furthermore, theparticular features, structures, or characteristics of any specificembodiment of the present invention may be combined in any suitablemanner with one or more other embodiments. It is to be understood thatother variations and modifications of the embodiments of the presentinvention described and illustrated herein are possible in light of theteachings herein and are to be considered as part of the spirit andscope of the present invention.

It will also be appreciated that one or more of the elements depicted inthe drawings/figures can also be implemented in a more separated orintegrated manner, or even removed or rendered as inoperable in certaincases, as is useful in accordance with a particular application.

Additionally, any signal arrows in the drawings/Figures should beconsidered only as exemplary, and not limiting, unless otherwisespecifically noted. Combinations of components or steps will also beconsidered as being noted, where terminology is foreseen as renderingthe ability to separate or combine is unclear.

The foregoing description of illustrated embodiments of the presentinvention, including what is described in the Abstract, is not intendedto be exhaustive or to limit the invention to the precise formsdisclosed herein. While specific embodiments of, and examples for, theinvention are described herein for illustrative purposes only, variousequivalent modifications are possible within the spirit and scope of thepresent invention, as those skilled in the relevant art will recognizeand appreciate. As indicated, these modifications may be made to thepresent invention in light of the foregoing description of illustratedembodiments of the present invention and are to be included within thespirit and scope of the present invention.

Thus, while the present invention has been described herein withreference to particular embodiments thereof, a latitude of modification,various changes and substitutions are intended in the foregoingdisclosures, and it will be appreciated that in some instances somefeatures of embodiments of the invention will be employed without acorresponding use of other features without departing from the scope andspirit of the invention as set forth. Therefore, many modifications maybe made to adapt a particular situation or material to the essentialscope and spirit of the present invention. It is intended that theinvention not be limited to the particular terms used in followingclaims and/or to the particular embodiment disclosed as the best modecontemplated for carrying out this invention, but that the inventionwill include any and all embodiments and equivalents falling within thescope of the appended claims. Thus, the scope of the invention is to bedetermined solely by the appended claims.

1. A method for installing a prosthesis into an undersized cavity, the undersized cavity providing a resistive force for installation, comprising: a) preparing a surface treatment for the prosthesis in advance of an installation of the prosthesis into the undersized cavity defining a surface-treated prosthesis; and b) installing said surface-treated prosthesis into the undersized cavity using an installation force less than the resistive force responsive to said surface treatment.
 2. The method of claim 1 wherein said surface treatment temporarily reduces said installation force wherein an extractive force to remove the prosthesis operates with respect to the resistive force and must exceed the resistive force to extract the prosthesis from the undersized cavity.
 3. The method of claim 2 wherein said surface treatment includes incorporation of an exterior frozen layer of sterile water that melts when said surface-treated prosthesis is installed into the undersized cavity.
 4. The method of claim 2 wherein said surface treatment includes incorporation of a slurry that is absorbed into the undersized cavity when said surface-treated prosthesis is installed into the undersized cavity. 5-6. (canceled)
 7. A method for producing a prosthesis for installation into an undersized cavity, the undersized cavity providing a resistive force for installation, comprising: a) manufacturing additively a structure for the prosthesis, said structure including a foundation and a surface; and b) during said manufacturing step a) establishing one or more portions of said structure with a bias for installation.
 8. The method of claim 7 wherein a first portion of said one or more portions includes an exterior of said surface.
 9. The method of claim 8 wherein said first portion includes a surface treatment producing said bias for insertion.
 10. The method of claim 9 wherein said surface treatment includes a plurality of microstructural surface features.
 11. The method of claim 10 wherein said surface treatment further includes an application of a surface material.
 12. The method of claim 7 wherein a first portion of said one or more portions includes a first region of said foundation, wherein a second portion of said one or more portions includes a second region of said foundation, and wherein said first portion and said second portion are cooperatively configured to produce a two-dimensional asymmetric stiffness implementing said bias for insertion.
 13. The method of claim 12 wherein said first portion includes a set of longitudinally extending ribs and wherein said second portion includes a set of laterally extending circumferential bands.
 14. The method of claim 12 wherein said first portion includes a first set of helical structures installed clockwise about an axis and wherein said second portion includes a second set of helical structures installed counterclockwise about said axis with said sets of helical structures cooperatively configured to produce a two-dimensional asymmetric stiffness implementing said bias for insertion.
 15. The method of claim 7 wherein said manufacturing additively step a) includes a step of three-dimensional printing of at least a portion of said structure.
 16. A prosthesis, comprising: a structure including a foundation and a surface treatment; wherein said surface treatment is configured for a first asymmetric installation bias favoring an installation over an extraction of said structure into a portion of prepared bone.
 17. The prosthesis of claim 16 wherein said foundation is configured for a second asymmetric installation bias favoring said installation over said extraction of said structure into said portion of prepared bone.
 18. A prosthesis, comprising: a structure including a foundation and a surface treatment; wherein said foundation is configured for a first asymmetric installation bias favoring an installation over an extraction of said structure into a portion of prepared bone. 